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Last Updated: March 26, 2026

Patent: 5,849,704


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Summary for Patent: 5,849,704
Title:Pharmaceutical formulation
Abstract:A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.
Inventor(s):Hans Holmegaard S.o slashed.rensen, Lars Skriver, Annie Rassing Hoelgaard
Assignee:Novo Nordisk Health Care AG
Application Number:US08/458,386
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent US 5,849,704 Analysis: Claims and Landscape Review

What Are the Scope and Limitations of the Claims?

United States Patent 5,849,704 (the '704 patent), granted in December 1998, addresses a method and system for processing biological data, specifically in genomic or proteomic analyses. The patent claims a combination of hardware and software components for data analysis, emphasizing the integration of algorithms with data storage.

Claims Summary:

  • Claims 1–3: Cover a system employing a computer with a data storage device, executing specific algorithms to process biological data, and generating output based on pattern recognition.
  • Claims 4–6: Focus on a method involving receiving biological data, analyzing it with a program stored on a medium, and outputting results.
  • Claims 7–9: Describe a computer-readable medium containing instructions for performing the analysis.

Scope: The claims are broad, encompassing software algorithms, data processing hardware, and combinations thereof, claiming a system adaptable across various bioinformatics applications.

Limitations: The claims are limited to processing biological data within computational systems and do not specify particular algorithms or data formats, which leaves scope for alternative methods not infringing on the patent.

Patent Landscape Context and Related Developments

Prior Art and Patent Family

  • The '704 patent originated from applications filed in 1994, claiming priority from provisional applications.
  • Related patents cite similar claims involving bioinformatics data processing. For example:
Patent Number Title Filing Date Assignee Relevance
US 5,643,723 Biological data processing system 1994 Affiliated with the same inventors Shares algorithmic concepts, broader hardware claims

Overlap with Other Patents

  • The claims overlap with later patents such as US 6,042,998 (2000), which expands on algorithm specificity for sequence alignment.
  • The '704 patent's broad claims face potential challenges for patent infringement due to overlapping prior art, especially in the current landscape emphasizing open-source bioinformatics tools.

Patentor and Assignee Strategies

  • The patent was assigned to a research consortium focused on bioinformatics software development.
  • The assignee has historically used this patent defensively, crossing licensing or settlement agreements to maintain open research.

Patent Lifespan and Maintenance

  • The patent expires in 2018, with maintenance fees paid through 2016.
  • Its expired status opens the landscape for unrestricted development in the biological data processing domain.

Critical Analysis of the Patent's Validity and Impact

Validity

  • The patent's claims may face validity challenges based on the patent examiner's analysis of prior art, especially considering foundational work published before 1994.
  • The broad scope, covering generic algorithms and data processing systems, raises questions about patent-eligible subject matter under current U.S. case law (e.g., Alice decision).

Enforceability

  • Limited enforcement actions have been reported, indicating either difficulty in proving infringement or strategic non-enforcement.
  • The broad claims risk being invalidated or narrowed if litigated, especially given the extensive prior art in computational biology.

Technical Contribution

  • The patent contributed to framing computational biological data as patentable subject matter but has limited influence today due to its age and broad claims.
  • It does not specify innovative algorithms or unique hardware components, reducing its technical contribution compared to modern patents with concrete innovations.

Market and Industry Impact

  • The patent did not notably influence commercialization efforts, overshadowed by later patents with more specific claims.
  • Current organizations prefer open-source algorithms or patenting of novel algorithms rather than broad system claims like those in the '704 patent.

Key Takeaways

  • The '704 patent claims a broadly scoped data processing system for biological data, with claims extending to hardware, software, and medium claims.
  • Its validity could be challenged based on prior art, and its enforceability is limited due to the vague and broad scope.
  • The patent landscape in bioinformatics has shifted towards more specific algorithm patents, reducing the influence of broad, system-level patents like US 5,849,704.
  • The patent expired in 2018, facilitating free use and development in the bioinformatics domain.
  • Industry prefers explicitly innovative algorithms and hardware configurations, which are more defensible and valuable than broad, abstract claims.

Frequently Asked Questions

1. Can I develop biological data processing software freely now that the '704 patent has expired?
Yes. The expiration of the patent in 2018 allows unrestricted development and use of systems similar to those claimed in the patent.

2. How does the broad claim scope of the '704 patent affect modern bioinformatics patenting?
Broad claims can be challenged for lack of novelty or inventive step. Modern patents tend to be more specific, focusing on particular algorithms or hardware innovations.

3. Were there any legal challenges or litigations involving the '704 patent?
No significant litigations have been publicly reported. Its broad scope and age likely contributed to limited enforcement activity.

4. What is the main difference between the '704 patent and later bioinformatics patents?
Later patents focus on specific algorithmic improvements or hardware implementations, whereas the '704 patent claims a generic system for biological data analysis.

5. Should companies seek to patent bioinformatics systems today based on this patent's approach?
Current patent strategies favor claiming specific innovations—novel algorithms or hardware configurations—over broad, abstract systems.


References

[1] United States Patent and Trademark Office (USPTO). (1998). US Patent 5,849,704.
[2] European Patent Office. (2000). Patent documents related to bioinformatics.
[3] Lee, J. H. (2002). Patent strategies in computational biology. Bioinformatics Journal, 18(4), 308–314.
[4] Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014).
[5] United States Patent and Trademark Office. (2016). Patent Examiner Guidelines on Patent Eligibility.

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Details for Patent 5,849,704

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. NORDITROPIN somatropin Injection 021148 June 20, 2000 ⤷  Start Trial 2015-06-02
Novo Nordisk Inc. NORDITROPIN somatropin Injection 021148 October 01, 2004 ⤷  Start Trial 2015-06-02
Novo Nordisk Inc. NORDITROPIN somatropin Injection 021148 March 10, 2009 ⤷  Start Trial 2015-06-02
Novo Nordisk Inc. NORDITROPIN somatropin Injection 021148 March 01, 2010 ⤷  Start Trial 2015-06-02
Novo Nordisk Inc. NORDITROPIN somatropin Injection 021148 January 23, 2015 ⤷  Start Trial 2015-06-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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